Implantable coaptation assist devices with sensors and associated systems and methods

ABSTRACT

Coaptation assist device for repairing cardiac valves and associated systems and methods are disclosed herein. A coaptation assist device configured in accordance with embodiments of the present technology can include, for example, a fixation member configured to press against cardiac tissue proximate to a native valve annulus, and a stationary coaptation structure extending away from the fixation member. The coaptation structure can include an anterior surface configured to coapt with a first native leaflet during systole and a posterior surface configured to displace at least a portion of a second native leaflet. The device also includes at least one sensor configured to detect parameters associated with at least one of cardiac function and device functionality. The sensors can be pressure sensors configured to detect left atrial pressure and/or left ventricular pressure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.16/745,246 filed Jan. 16, 2020, now allowed, which claims priority toand the benefit of U.S. Provisional Application No. 62/793,273, filedJan. 16, 2019, both of which are incorporated herein by reference intheir entirety.

TECHNICAL FIELD

The present technology relates generally to valve repair devices. Inparticular, several embodiments are directed to implantable coaptationassist devices with sensors and associated systems and methods.

BACKGROUND

Conditions affecting the proper functioning of the mitral valve include,for example, mitral valve regurgitation, mitral valve prolapse andmitral valve stenosis. Mitral valve regurgitation is a disorder of theheart in which the leaflets of the mitral valve fail to coapt intoapposition at peak contraction pressures, resulting in abnormal leakingof blood from the left ventricle into the left atrium. There are severalstructural factors that may affect the proper closure of the mitralvalve leaflets. For example, many patients suffering from heart diseasehave an enlarged mitral annulus caused by dilation of heart muscle.Enlargement of the mitral annulus makes it difficult for the leaflets tocoapt during systole. A stretch or tear in the chordae tendineae, thetendons connecting the papillary muscles to the inferior side of themitral valve leaflets, may also affect proper closure of the mitralannulus. A ruptured chordae tendineae, for example, may cause a valveleaflet to prolapse into the left atrium due to inadequate tension onthe leaflet. Abnormal backflow can also occur when the functioning ofthe papillary muscles is compromised, for example, due to ischemia. Asthe left ventricle contracts during systole, the affected papillarymuscles do not contract sufficiently to effect proper closure.

Mitral valve prolapse, or when the mitral leaflets bulge abnormally upinto the left atrium, causes irregular behavior of the mitral valve andmay also lead to mitral valve regurgitation. Normal functioning of themitral valve may also be affected by mitral valve stenosis, or anarrowing of the mitral valve orifice, which causes impedance of fillingof the left ventricle in diastole.

Mitral valve regurgitation is often treated using diuretics and/orvasodilators to reduce the amount of blood flowing back into the leftatrium. Other treatment methods, such as surgical approaches (open andintravascular), have also been used for either the repair or replacementof the valve. For example, typical repair approaches have involvedcinching or resecting portions of the dilated annulus.

Cinching of the annulus has been accomplished by the implantation ofannular or peri-annular rings which are generally secured to the annulusor surrounding tissue. Other repair procedures have also involvedsuturing or clipping of the valve leaflets into partial apposition withone another.

Alternatively, more invasive procedures have involved the replacement ofthe entire valve itself where mechanical valves or biological tissue areimplanted into the heart in place of the mitral valve. These invasiveprocedures are conventionally done through large open thoracotomies andare thus very painful, have significant morbidity, and require longrecovery periods.

With many repair and replacement procedures, however, the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may result in additional problems for the patient. Moreover, manyof the repair procedures are highly dependent upon the skill of thecardiac surgeon where poorly or inaccurately placed sutures may affectthe success of procedures.

Compared to other cardiac valves, portions of the mitral valve annulushave limited radial support from surrounding tissue and the mitral valvehas an irregular, unpredictable shape. For example, the inner wall ofthe mitral valve is bound by only a thin vessel wall separating themitral valve annulus from the inferior portion of the aortic outflowtract. As a result, significant radial forces on the mitral annuluscould lead to collapse of the inferior portion of the aortic tract withpotentially fatal consequences. The chordae tendineae of the leftventricle are often an obstacle in deploying a mitral valve repairdevice. The maze of chordae in the left ventricle makes navigating andpositioning a deployment catheter that much more difficult in mitralvalve repair. Given the difficulties associated with current procedures,there remains the need for simple, effective, and less invasive devicesand methods for treating dysfunctional heart valves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale, and instead emphasis is placed on illustratingclearly the principles of the present disclosure. For ease of reference,throughout this disclosure identical reference numbers and/or lettersare used to identify similar or analogous components or features, butthe use of the same reference number does not imply that the partsshould be construed to be identical. Indeed, in many examples describedherein, identically numbered components refer to different embodimentsthat are distinct in structure and/or function. The headings providedherein are for convenience only.

FIG. 1A is a top view of a coaptation assist device configured inaccordance with some embodiments of the present technology.

FIG. 1B illustrates a mitral valve repair and monitoring systemincluding the coaptation assist device of FIG. 1A implanted in a heartin accordance with some embodiments of the present technology.

FIG. 2A is a top of a coaptation assist device configured in accordancewith some embodiments of the present technology.

FIG. 2B is a side view of a mitral valve repair and monitoring systemincluding the coaptation assist device of FIG. 2A in accordance withsome embodiments of the present technology.

FIG. 2C is a top view of the coaptation assist device of FIG. 2A in adelivery state in accordance with some embodiments of the presenttechnology.

FIGS. 3A and 3B are top and side views, respectively, of a coaptationassist device configured in accordance with some embodiments of thepresent technology.

FIGS. 4A and 4B are side views of a coaptation assist device shownimplanted in the heart during systole and diastole, respectively, inaccordance with some embodiments of the present technology.

FIGS. 5A and 5B are side views of illustrating stages of a procedure fordelivering a sensor to an implanted coaptation assist device inaccordance with some embodiments of the present technology.

DETAILED DESCRIPTION

Implantable coaptation assist devices with sensors and associatedsystems and methods are disclosed herein. In some embodiments, forexample, a coaptation assist device (also referred to as a “mitral valverepair device”) includes (a) a coaptation structure that takes the placeof a native leaflet and coapts with one or more opposing native leafletsduring systole, and (b) one or more sensors that monitor variousphysiological and/or device parameters that can be used to dictate orguide patient care. As such, the present technology may be referred toas a “smart” heart valve repair device. Specific details of severalembodiments of the technology are described below with reference toFIGS. 1A-5B. Although many of the embodiments are described below withrespect to implant devices, systems, and methods for repair of a nativemitral valve, other applications and other embodiments in addition tothose described herein are within the scope of the technology. Forexample, the present technology may be used at other target sites, likethe tricuspid valve. Additionally, several other embodiments of thetechnology can have different configurations, components, or proceduresthan those described herein, and that features of the embodiments showncan be combined with one another. A person of ordinary skill in the art,therefore, will accordingly understand that the technology can haveother embodiments with additional elements, or the technology can haveother embodiments without several of the features shown and describedbelow with reference to FIGS. 1A-5B.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a valve repair device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various valve repairdevices described herein, “proximal” can refer to a position closer tothe operator of the device or an incision into the vasculature, and“distal” can refer to a position that is more distant from the operatorof the device or further from the incision along the vasculature (e.g.,the end of the catheter). With respect to a heart valve repair device,the terms “proximal” and “distal” can refer to the location of portionsof the device with respect to the direction of blood flow. For example,proximal can refer to an upstream position or a location where blood,during its typical, non-regurgitating path, flows toward the device(e.g., inlet region of the native valve), and distal can refer to adownstream position or a location where blood flows away the device(e.g., outflow region of the native valve).

Overview

The present technology includes devices for treating mitral valveregurgitation that places a coaptation structure (also referred to as a“baffle”) over a portion of a native valve leaflet to addressregurgitation caused by dilation of the annulus or deterioration of thenative leaflet. The coaptation structure fills at least a portion of thespace taken by the closed native leaflet and extends beyond that spaceto re-establish coaptation with the surrounding leaflets. For example,the coaptation structure may extend in front of a central portion of theposterior leaflet (i.e., P2 of the posterior leaflet), pushing theposterior leaflet back toward the ventricular wall, such that thecoaptation structure is positioned to coapt with the anterior leafletduring systole. The coaptation structure is retained in place by afixation member (also referred to as an “anchoring member” or “brim”)configured to anchor to cardiac tissue of the left atrium whichsurrounds the mitral annulus. The fixation member can be an expandablenitinol mesh tube (e.g., a stent) that shaped to conform to the walls ofthe left atrium just above the mitral annulus. In various embodiments,the fixation member may also or alternatively include portions thatpress against and anchor to sub-annular tissue. In some embodiments, thefixation member has cleats or other frictional elements to hold it inplace against the atrial wall. Over a period after implantation (e.g., 3days, 2 weeks, 1 month, 2 months), the fixation member or portionsthereof become covered by a layer of tissue, and this tissue ingrowthadheres it permanently to the atrial wall. The device can furtherinclude one or more clips that extend from the fixation member and/orthe coaptation structure to a position behind individual mitral valveleaflets to the sub-annular space for further stabilization of theimplant. In some embodiments, for example, the device includes a clipthat reaches under the P2 or other portion of the posterior leaflet upto the sub-annular space and further stabilizes the implant. Furtherdescriptions of implant devices with coaptation assist devices are alsodescribed in International Patent Application No. PCT/US2018/043566,filed Jul. 24, 2018, and in International Patent Application No.PCT/US2018/061126, filed Nov. 14, 2018, each of which is incorporated byreference in its entirety.

The mitral repair device includes at least one sensor (also referred toas a “sensing component”) for detecting parameters associated withcardiac function, other physiological parameters, and/or devicefunctionality to provide real-time monitoring of the detectedparameters. The sensor can include a pressure sensor, an accelerometer,a strain gauge, an acoustic sensor (e.g., a microphone), a flow sensor,a temperature sensor, and/or other type of sensing mechanism. The sensorcan be communicatively coupled to a communication component ortransmitter, such as an antenna, that wirelessly transmits the detectedmeasurements to an external computing device outside the body. From theexternal computing device and/or a device communicatively coupledthereto, the data can be displayed and/or further analyzed via softwaretechniques (e.g., compared against threshold values, interpreted todetermine related parameters). The sensor can be powered via an externalsource and/or with a battery or capacitive element integrated into thedevice or sensor itself.

Since the mitral repair device includes portions that, when implanted,reside in both the atrium and the ventricle, the mitral valve repairdevice can include sensors in both the atrium and the ventricle toprovide real-time monitoring and wireless communication of parametersassociated with both locations, such as atrial pressure and ventricularpressure. When the mitral valve repair device includes a pressure sensor(e.g., a capacitive pressure microsensor) in the atrial region (e.g., onor extending from the fixation member), the device can detect leftatrial pressure (“LAP”). The monitoring of LAP may be of particularinterest because of the potential for pressure-guided management ofcongestive heart failure (“CHF”). Many patients suffering from mitralvalve disease also have CHF, which may be a result of the untreatedmitral regurgitation or other conditions that damage or weaken theheart, such as coronary artery disease and heart attack, high bloodpressure, cardiomyopathy, heart arrhythmias, and other chronic disease.The real-time monitoring of parameters, such as LAP and/or pulmonaryartery pressure, via the sensor device allows the clinician toeffectively manage CHF patients and catch worsening conditions beforethe onset of symptoms. LAP monitoring can also provide a way to monitorproper device function as it relates to the elimination of mitralregurgitation (i.e., increased regurgitation would cause increased LAP).

When the mitral valve repair device includes a pressure sensor in theventricular region (e.g., on or within the coaptation structure, on orwithin the clip), the device can measure left ventricular pressure(“LVP”). This can provide a means of evaluating left ventricle (“LV”)contractility (i.e., the rate of change of LV pressure or LV dP/dt),which is an important indicator of ventricular function. The ability ofthe sensor device to detect LVP can also provide an accurate measure ofpeak systolic arterial pressure and may serve as an indicator of aorticstenosis.

When the mitral valve repair device includes pressure sensors in boththe atrial and ventricular regions, the device can be configured tomonitor the differential pressure between the LV and the left atrium(“LA”). During diastole the differential pressure may provide an earlyindication of mitral stenosis, whereas during systole the differentialpressure may provide an indication of mitral regurgitation. Carefulanalysis of these two measurements (i.e., LVP and LAP) over the cardiaccycle may also yield estimates of cardiac output.

In some embodiments, the mitral valve repair device may includeadditional or other sensors. For example, the device can include one ormore accelerometers and/or one or more strain gauges that can monitordevice motion and/or epicardial wall motion. As another example, themitral valve repair device may include a microphone to detect acousticsignals in the heart, and these acoustic signals can be analyzed (e.g.,via machine learning at a remote device) to provide importantinformation regarding the function of the valves and chambers of theheart. As yet another example, the mitral valve repair device caninclude a flow sensor (e.g., an inductively powered flow sensor)incorporated into the atrial-facing side of the coaptation structure tomeasure flow patterns throughout the cardiac cycle and to detectimprovement or worsening of mitral regurgitation.

Selected Embodiments of Mitral Repair Devices with Sensors

FIG. 1A is a top view of a coaptation assist device 100 (also referredto as a “mitral valve repair device 100” or “device 100”) configured inaccordance with some embodiments of the present technology, and FIG. 1Billustrates a mitral valve repair and monitoring system 101 (“system101”) including the device 100 of FIG. 1A implanted in a heart inaccordance with some embodiments of the present technology. The device100 includes a fixation member 102 (also referred to as the “atrialfixation member 102”) configured to anchor the device 100 to cardiactissue proximate to a native mitral valve annulus, a coaptationstructure 104 configured to coapt with an opposing native leaflet, andat least one sensor (identified individually as a first sensor 106 a anda second sensor 106 b; referred to collectively as “sensors 106”) fordetecting one or more parameters (e.g., pressure, acceleration)associated with cardiac function and/or the functionality of the device100. As shown in FIG. 1B, the system 101 can further include an externaldevice 122 communicatively coupled to the sensors 106. The externaldevice 122 can interrogate and/or power the sensors 106 to enable aclinician, technician, the patient, and/or others involved in thepatient's care to monitor the patient's cardiac health and/or deviceperformance.

The fixation member 102 can include an expandable mesh structure 108(e.g., a stent) having an oval or circular shape in the deployed stateand defining an open central lumen 110 that allows blood to passtherethrough. The mesh structure 108 can be a stent made of nitinol orother suitable stent material. As shown in FIG. 1B, the fixation member102 can shaped to conform to the walls of the left atrium (“LA”) justabove the mitral annulus to secure the device 100 to the supra-annulartissue. After implantation (e.g., 3 days, 2 weeks, 1 month, 2 months),the fixation member 102 or portions thereof become covered by a layer oftissue, and this tissue ingrowth adheres the device 100 permanently tothe atrial wall. The fixation member 102 may also include cleats orother frictional elements to enhance fixation and facilitate tissueingrowth. In some embodiments, the fixation member 102 has asemi-circular or other shape that does not extend fully around thecircumference of the native valve. In some embodiments, the fixationmember 102 may also or alternatively include one or more portions thatpress against sub-annular tissue to provide sub-annular device fixation.In some embodiments,

The coaptation structure 104 extends away from a portion of the fixationmember 102 in generally downstream direction (along the longitudinalaxis of either the central lumen 110 or the fixation member 102) and atleast a portion of the coaptation structure 104 extends radially inwardfrom the fixation member 102 into the central lumen 110 to approximate aclosed position of the native leaflets. In the deployed state, theposition of the coaptation structure 104 relative to the fixation member102 is at least substantially fixed. Thus, unlike native leaflets thatmove back and forth to open and close the native valve, the coaptationstructure 104 remains stationary during diastole and systole. Thecoaptation structure 104 can have an anterior portion 112 with a smooth,atraumatic surface for coapting with at least a portion of one or morenative leaflets and a posterior portion 114 configured to displace and,optionally, engage at least a portion of another native leaflet. Asshown in FIG. 1B, for example, the coaptation structure 104 can extendin front of the native posterior leaflet PL into the opening of thenative mitral valve MV such that the anterior portion 112 is positionedto re-establish coaptation with the opposing anterior leaflet AL. Thecoaptation structure 104 can include struts 116 that form a frame-likestructure (e.g., a mesh structure, a laser cut stent frame) and acovering 118 (e.g., a fabric) extending over at least a portion of thestruts 116 to provide a smooth suitable surface for coaptation at theanterior portion 112. The covering 118 may also extend over the struts116 along the posterior portion 114 and between the anterior andposterior portions 112, 114 in a manner that forms lateral sidewalls.

In some embodiments, the device 100 can further include one or moreclips 109 that extend from the fixation member 102 in a downstreamdirection and/or the coaptation structure 104 to a position behind thenative leaflet (e.g., the posterior leaflet PL) displaced by thecoaptation structure 104. The clip 109 may grasp the native leafletand/or engage sub-annular cardiac tissue for sub-annular stabilizationof the device 100. In some embodiments, for example, the device 100includes a clip that reaches under the central portion (i.e., P2) of theposterior leaflet PL up to the sub-annular space.

The device 100 has a first or delivery state in which the device 100 iscompressed (e.g., via crimping) to a reduced cross-section for deliveryto the mitral valve and a second or deployed state shown in FIGS. 1A and1B in which the device 100 has a larger cross-section for engagementwith the native valve. In some embodiments, the cross-sectionaldimension of the device 100 in the delivery state is less than 20 Fr(e.g., 16-18 Fr) to facilitate intravascular delivery via a trans-septalapproach.

The one or more sensors 106 can be coupled to various portions of thedevice 100, and the locations can be selected based upon the desireddetected parameter and the type of sensor. In embodiment illustrated inFIGS. 1A and 1B, for example, the first sensor 106 a is coupled to thefixation member 102 such that, after implantation, the first sensor 106a is positioned in within the left atrium LA, while the second sensor106 b is coupled to the coaptation structure 104 such that it ispositioned in the left ventricle LV after implantation. In particular,the first sensor 106 a is attached (e.g., welded) to an atrial crownregion 120 on the anterior side of the fixation member 102, and thesecond sensor 106 b is attached (e.g., welded) to the struts 116 of thecoaptation structure 104. In the illustrated embodiment, the device 100includes two sensors 106. In other embodiments, the device 100 caninclude a singular sensor 106 or more than two sensors 106.

In some embodiments the sensors 106 are pressure sensors, such ascapacitive pressure sensors. Accordingly, in the configuration shown inFIGS. 1A and 1B, the first sensor 106 a can measure LAP throughout thecardiac cycle and second sensor 106 b can measure LVP. The externalreader device 122 can establish a connection to the individual sensors106 via an antenna associated with each sensor 106. For example, thestent frame of the fixation member 102 and the struts 116 of thecoaptation structure 104 can be electroplated to define antennae for thefirst and second sensors 106 a and 106 b, respectively. Using theseantennae, the external reader device 122 can communicate with thesensors 106 to obtain the detected sensor data.

Capacitive pressure sensors (e.g., capacitive micro-electro-mechanicalsystem (“MEMS”) pressure sensors) do not require batteries or electricalcomponents and are small enough to be placed in the delivery state(e.g., crimped) with the device 100 to a diameter of 16-20 Fr. Thecapacitive pressure sensors function as inductive-capacitive tanks (LCtanks) and, as such, include a fixed inductive element and a capacitiveelement that comprises flexible plates whose separation varies withpressure. As a result, the resonant frequency of such a device variesaccurately with pressure. Such capacitive pressure sensors for remotepressure monitoring (e.g., manufactured by CardioMEMs, AbbottLaboratories, Atlanta, GA. USA) have a footprint of approximately 15mm×2 mm×3.5 mm. A sensor of this size or smaller can fit on or withinthe coaptation structure 104 and/or on the atrial fixation member 102.In some embodiments, the size of the capacitive pressure sensors can bedecreased considerably by placing the inductive element elsewhere in thedevice, such as around the fixation member 102. For example, theinductive element (e.g., a coil) can extend around the atrial edgeregion 120 of the fixation member 102 and/or attach to the atrial tipportions 124 of the fixation member's stent frame. This configuration isexpected to enhance the exposure of the inductive element to thestimulating external field (e.g., magnetic field).

In some embodiments, the inductive element may be enhanced or optimizedby using a coil with a number of low-resistance wires (e.g., goldwires). In this embodiment, the coil can be isolated from the externalelectromagnetic stimulating fields to prevent the stents and struts ofthe fixation member 102 and/or the coaptation structure 104 from actingas a Faraday cage. For example, the desired isolation can be attained byspacing the inductive element (e.g., the coil(s)) apart from a middle orcentral portion of the fixation member 102, such as at the top (atrial)edge of the fixation member 102 (e.g., along the atrial crown region120). In this arrangement, the inductive element can be exposed to andstimulated by the external energy (e.g., an external magnetic field)without interference from the fixation member frame.

It is also contemplated that the inductive element of the capacitivesensor 106 is defined by the stent(s) of the fixation member 102 itself.This can be achieved by electroplating (e.g., gold-plating) the meshstructure 108 to decrease electrical resistance and increaseweldability. In this embodiment, the stent of the mesh structure 108includes two ends (e.g., formed by cutting the stent frame) at somepoint in its circumference to electrically isolate the portions fromeach other. For example, to facilitate keeping the ends electricallyisolated from each other, the ends can be positioned in the locationcorresponding to the central region of the posterior leaflet PL wherethe mesh structure 108 attaches to the coaptation structure 104. The cutends can be connected to the capacitive component of the pressuresensor.

The external device 122 (also referred to as “an external wirelessreader device 122” and an “external stimulation-detection device 122”)can communicate with the sensors 106 via an external antenna tointerrogate the sensors 106. If the sensors 106 are capacitive sensorsthat detect pressure using the tank circuit (also referred to as an “LCcircuit” or a “resonant circuit”) described above, then the externaldevice 122 can stimulate the circuit via an oscillating externalmagnetic field at a frequency close to the resonant frequency of thecircuit, and the resulting tank circuit resonant frequency can then bedetected via the external device 122. Since the resonant frequency isdetermined by the inductance and capacitance of the circuit, thedetected resonant frequency can be used to determine the intracardiacpressure (e.g., processed via the external device 122 and/or othercomputing system). The resonant frequency of the LC circuit will bespecific to the circuit components themselves, such as thespecifications of the inductor, capacitor, relative positions of thesefeatures on the mitral repair device 100, and the features of the mitralrepair device 100 itself. For example, in some embodiments the resonantfrequency of the LC circuit may be 100 kHz to 100 MHz, with smallerinductors having higher resonant frequencies than larger inductors. Ifmore than one tank circuit is being used (e.g., at an atrial portion ofthe device 100 for measuring LAP and at a ventricular portion of thedevice 100 for measuring LVP), the tank circuits could be designed toresonate at significantly different frequencies, which would allow bothcircuits (and therefore both sensors 106) to be interrogated by theexternal device 122 simultaneously without interfering with each other.Alternatively, the two or more circuits could be interrogatedsequentially, alternating between them at predefined intervals (e.g.,every 1-50 milliseconds).

In some embodiments, the external device 122 may also be used to powerthe sensors 106. For example, the external device 122 may include asource of radiofrequency waves, which have shown to be able to powerimplantable sensors even at a depth of 10 cm from a distance of 1 meter.In other embodiments, a separate external device can provide the energysource for the sensors 106.

The external stimulation-detection device 122 may be carried by orintegrated into a belt worn around the patient's chest, a vest, aremovable pad adhered to the patient's skin or clothing, and/or anotherdevice that can be positioned close enough to the mitral repair device100 and transmit energy (e.g., RF waves, ultrasound) to stimulate,interrogate, detect, and/or wirelessly power the sensors 106 of theimplanted device 100. In some embodiments, the externalstimulation-detection device 122 may be a separate handheld device thatcan be used by the patient, a physician, and/or another party involvedin the patient's care. The external device 122 can also include awireless communications detector (e.g., an antenna) that communicateswith the sensor 106 of the implanted mitral repair device to receivesensor data. This sensor data can be stored locally on the externaldevice 122 and/or communicated to a separate device (e.g., a smartphone, a cloud service, another remote system). In some embodiments, thedetector can be part of a device separate from the device that transmitsenergy to the implanted sensor.

Once the information has been detected from the one or more sensors 106,the data can be processed locally at the external device 122 and/ortransmitted to a separate device (e.g., a smart phone, tablet, backendprocessing system, cloud, devices associated with physicians,) via acommunication medium (e.g., WiFi, Bluetooth, etc.) for furtherprocessing and/or communication. The raw or processed data can be usedto assess various parameters associated with the patient's cardiacfunction (e.g., LVP, LAP) and/or functionality of the mitral repairdevice 100 (e.g., whether the device is operating as anticipated). Thisinformation can be conveyed to the patient via an application running ona device communicatively coupled to the system 101, such as thepatient's smart phone or tablet. The information can also oralternatively be communicated to physicians and/or others to remotelytrack the patient. In some embodiments, the system 101 can use thetracked data to initiate alarms for the patient (e.g., via a smartphone) and/or others involved in the patient's care based onpredetermined threshold parameters associated with cardiac function,overall patient health, and/or device functionality.

In various embodiments, the device 100 can include other types ofsensors in addition to or in place of the capacitive sensors 106described above. For example, the device may include a temperaturesensor 126 for detecting temperature. The temperature sensor 126 can beattached to the exterior or interior of the baffle structure 104, aportion of the fixation member 102, and/or another portion of the mitralrepair device 100. The temperature sensor 126 can detect temperatureand/or data that can be used to determine temperature, and thisinformation can be communicated to the external device 122 (e.g., via anantenna) for real-time monitoring of temperature surrounding theimplanted mitral valve repair device 100. In further embodiments, thedevice 100 can also or alternatively include other sensors positioned onor integrated therein that detect other parameters associated withcardiac function, other physiological parameters, and/or devicefunctionality.

FIG. 2A is a top view a coaptation assist device 200 (“device 200”)configured in accordance with some embodiments of the presenttechnology, and FIG. 2B illustrates a mitral valve repair and monitoringsystem 201 (“system 201”) including the device 200 of FIG. 2A inaccordance with some embodiments of the present technology. FIG. 2C is atop view of the device 200 of FIG. 2A in a delivery state in accordancewith some embodiments of the present technology. The system 201 and thedevice 200 of FIGS. 2A-2C can include various features similar to thefeatures of the system 101 and the device 100 described above withrespect to FIGS. 1A and 1B. For example, the device 200 includes thefixation member 102, the coaptation structure 104, and at least onesensor 206 configured to detect one or more parameters associated withcardiac function and/or device functionality. In the embodimentillustrated in FIGS. 2A-2C, however, the sensor 206 is a self-containedsensor with more sophisticated electronic circuitry. For example, thesensor 206 may be a self-contained pressure sensor integrating bothcapacitive and inductive elements.

As shown in the illustrated embodiment, the self-contained sensor 206can be attached to an anterior surface of the fixation member 102 viasutures, adhesive, welding, and/or other coupling mechanism to monitorpressure (e.g., LAP). In other embodiments, the sensor 206 can beaffixed to other portions of the fixation member 102 and/or otherportions of the device 200 (e.g., the coaptation structure 104). Thesensor microchip and antenna can be made from biocompatible materials,allowing for long-term implantability. As would be understood to thosehaving skill in the art, such self-contained sensors can have dimensionsof approximately 15 mm×2 mm×3.5 mm. In some embodiments, the fixationmember 102 can be an expanded stent cut from a 6 mm tube with a wallthickness of 0.25 mm-0.5 mm. As shown in FIG. 2C, such dimensions allowsufficient inner cross-sectional area (e.g., 5 mm inner diameter) forthe sensor 206 to fit inside of the fixation member 102 when compressedto the deployment state (e.g., 18 Fr outer diameter (6 mm)). In theseand other embodiments, the device 200 can include a plurality ofself-contained sensors 206 coupled to various portions of the device 200and/or one or more types of sensors (e.g., an LC circuit pressuresensor, strain gauges, microphones, flow sensors, temperature sensors).

Referring to FIG. 2B, the system 201 can further includes an element topower the device 200 and a transmitter to send detected data to theexternal reader device 122. The power for this system 201 can come froman inductive coil stimulated by an oscillating external magnetic field.It might alternatively come from an external ultrasonic pressure wave,or from other sources. This external power source may be integrated intothe external reader device 122 or a separate external device. In someembodiments, the device 200 may include a power storage element, such asa capacitor or battery, in addition to or instead of the external powersource. For example, the device 200 may store power until it has enoughenergy to measure via the sensor 206 and transmit via the associatedantenna for a certain period of time, such as one or more heartbeats. Insome embodiments, the antenna is integrated into the sensor 206. In someembodiments, the fixation member 102 or the coaptation structure 104itself may serve as an antenna to improve transmission of the signal tothe external reader device 122.

In some embodiments, the sensor 206 can include one or more surfaceacoustic wave (“SAW”) sensors for monitoring pressure monitoring. SAWsensors have been shown to be reliable for detecting in vivo pressuremeasurements. In addition, the SAW sensors do not require a powersource, have long term stability, are small in size, and can communicatewirelessly with external devices positioned near the sensors.Furthermore, the SAW sensor can be configured to be independentlysensitive to pressure and temperature.

FIG. 3A is a top view a coaptation assist device 300 (“device 300”)configured in accordance with some embodiments of the presenttechnology, and FIG. 3B illustrates a mitral valve repair and monitoringsystem 301 (“system 301”) including the device 300 of FIG. 3A inaccordance with some embodiments of the present technology. The system301 and the device 300 of FIGS. 3A and 3B can include various featuressimilar to the features of the systems 101, 201 and the devices 100, 200described above with respect to FIGS. 1A-2C. For example, the device 300includes the fixation member 102, the coaptation structure 104, and atleast one sensor 306. In the embodiment illustrated in FIGS. 3A and 3B,the sensor 306 incudes an accelerometer for measuring device and/orcardiac motion. The accelerometer 306 can be included in the bafflestructure 104 to monitor device motion and predict potential devicefailure or migration. For example, the accelerometer 306 may be anchoredto the baffle covering 118 or baffle struts 116 (i.e., the frame of thecoaptation structure 104), and be positioned within the body of thecoaptation structure 104, along an outward-facing wall of the coaptationstructure 104, and/or on another portion of the coaptation structure104. In some embodiments, the accelerometer 306 may be freely positionedwithin the interior compartment defined by the walls of the coaptationstructure 104. In this embodiment, the natural clotting that occurswithin the compartment after device implantation eventually causes thefree-floating accelerometer 306 to immobilize and maintain a fixedposition within the coaptation structure 104. There is a small,predictable amount of motion (e.g., as indicated by arrow A) that occursin the coaptation structure 104 throughout the cardiac cycle due to thesystolic pressure load on the device 300. If this motion increasessuddenly, it could be indicative of device movement or fracture. Thus,the accelerometer 306 can detect such movement to provide an earlysignal of potential device abnormalities to allow for early interventionbefore device failure.

FIGS. 4A and 4B illustrate a mitral valve repair and monitoring system401 (“system 401”) including a coaptation assist device 400 (“device400”) shown implanted in a heart during systole and diastole,respectively, in accordance with some embodiments of the presenttechnology. The system 401 and the device 400 of FIGS. 4A and 4Bincludes various features similar to the features of the systems 101,201, 301 and the devices 100, 200, 300 described above with respect toFIGS. 1A-3B. For example, the device 400 includes the fixation member102, the coaptation structure 104, and at least one sensor 406. In theembodiment illustrated in FIGS. 4A and 4B, the device 400 furtherincludes an appendage 428 extending from the posterior side of thecoaptation structure 104 or the posterior clip 109 and the sensor 406 iscarried by the appendage 428. The sensor 406 may be an accelerometerthat can be used to detect LV wall motion. The appendage 428 can includea flexible loop or frame structure 430 (e.g., a nitinol loop or stentstructure) that is shaped to be biased outwardly away from thecoaptation structure 104 such that the appendage 428 contacts or pressesagainst the LV wall and move with the LV wall throughout the cardiaccycle. The loop/frame structure 430 can include a fabric covering 432,such as PET, to promote rapid tissue ingrowth. The accelerometer 406 canbe attached to the frame structure 430, the covering 432, and/orpositioned within the body of the appendage 428 such that it moves withand detects appendage movement imparted by the adjacent ventricularwall. Ventricular wall motion can be used to assess changes inventricular function. In some embodiments, the sensor 406 is a straingauge rather than an accelerometer, or the device 400 includes both anaccelerometer and a strain gauge. The strain gauge can be affixed to theframe structure 430 and/or other portion of the appendage to detect whenthe cardiac wall applies force against the appendage 428. The sensor 406can be powered wirelessly by radiofrequency waves and/or other externalpower source provided (e.g., the external device 122 of FIG. 1B). Inother embodiments, sensor 406 can include or be coupled to a powersource on the device 400 itself. In some embodiments, the device 400 caninclude accelerometers, strain gauges on other or additional portions ofthe device 400 to determine cardiac tissue movement and/or devicefunctionality.

FIGS. 5A and 5B are side views of illustrating stages of a procedure fordelivering a sensor 506 to an implanted coaptation assist device 500(“device 500”) in accordance with some embodiments of the presenttechnology. The device 500 of FIGS. 5A and 5B includes various featuressimilar to the features of the devices 100, 200, 300, 400 describedabove with respect to FIGS. 1A-4B. For example, the device 500 includesthe fixation member 102, the coaptation structure 104, and at least onesensor 506. As described above, the sensors may be attached to orintegrated with the devices before delivery such that the device and thesensor are delivered as a unit together to the target site proximate tothe mitral valve. As illustrated in FIGS. 5A and 5B, however, the mainbody of the device 500 (e.g., the fixation member 102 and the coaptationstructure 104) and the sensor 506 can be delivered sequentially. Forexample, to accommodate packing the device 500 into a small catheter 534of a delivery system 536 (only distal end of catheter 534 shown), any ofthe sensor components described above can be deployed after the fixationmember 102 and the coaptation structure 104 are already in place in theanatomy. As shown in FIG. 5A, for example, lines 538 (e.g., sutures)extending from the fixation member 102 back into the delivery system 536can provide “rails” upon which the sensor 506 be slid and, once properlyposition with respect to the device 500, locked into place.

The implant devices described above can be delivered via a trans-femoralapproach and/or other approach that passes the devices through theseptal wall between chambers of the heart. It can also be delivered viaminimally-invasive-surgical trans-apical or trans-atrial approaches, orvia open surgical placement. A catheter-based delivery could takeadvantage of various delivery system concepts for implanting heart valveprosthesis and/or cardiac repair devices to target sites proximate tothe mitral valve, the aortic valve, the tricuspid valve, and/or otherportions of the heart.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. The various embodimentsdescribed herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

1. A method of monitoring a native mitral valve, the method comprising:deploying a coaptation structure of a mitral valve repair device suchthat the coaptation structure displaces a first native leaflet of anative mitral valve of a heart and coapts with a second native leafletof the native mitral valve during systole; and interrogating, via anexternal device, a pressure sensor of the mitral valve repair device toreceive pressure data during cardiac cycles of the heart.
 2. The methodof claim 1, further comprising: deploying a fixation member of themitral valve repair device to a left atrium of the heart such that thefixation member presses against cardiac tissue in the left atrium; afterdeploying the fixation member, sliding the pressure sensor along suturesextending from a delivery system to the fixation member; and couplingthe pressure sensor to the deployed fixation member.
 3. The method ofclaim 1, further comprising: detecting left ventricular wall movementduring the cardiac cycles via an accelerometer and/or strain gauge ofthe mitral valve repair device.
 4. The method of claim 1, furthercomprising powering the pressure sensor via the external device.
 5. Themethod of claim 1, further comprising deploying a fixation member of themitral valve repair device to a left atrium of the heart such that thefixation member presses against cardiac tissue in the left atrium,wherein the pressure sensor is coupled to the fixation member, andwherein the pressure data comprises a left atrial pressure within theleft atrium during the cardiac cycles.
 6. The method of claim 1 whereinthe pressure sensor is coupled to the coaptation structure, and whereinthe pressure data comprises left ventricular pressure within a leftventricle of the heart during the cardiac cycles.
 7. The method of claim1, further comprising: deploying a fixation member of the mitral valverepair device to a left atrium of the heart such that the fixationmember presses against cardiac tissue in the left atrium, wherein thepressure sensor is a first pressure sensor coupled to the fixationmember, wherein the pressure data is first pressure data comprising leftatrial pressure within the left atrium during the cardiac cycles; andinterrogating, via the external device, a second pressure sensor of themitral valve repair device coupled to the coaptation structure toreceive second pressure data comprising left ventricular pressure withina left ventricle of the heart during the cardiac cycles.
 8. The methodof claim 7 wherein the first pressure sensor comprises a first resonantcircuit having a first resonant frequency, wherein the second pressuresensor comprises a second resonant circuit having a second resonantfrequency substantially different than the first resonant frequency, andwherein interrogating the first pressure sensor and interrogating thesecond pressure sensor occurs substantially simultaneously.
 9. Themethod of claim 7 wherein interrogating the first pressure sensor andinterrogating the second pressure includes sequentially interrogatingthe first pressure sensor and interrogating the second pressure sensor.10. The method of claim 1, further comprising deploying a fixationmember of the mitral valve repair device to a left atrium of the heartsuch that the fixation member presses against cardiac tissue in the leftatrium, wherein: the fixation member comprises a wire mesh structure; atleast a portion of the wire mesh structure defines an antenna; andinterrogating the pressure includes establishing a wireless connectionto the pressure sensor via the antenna.
 11. The method of claim 1wherein: the coaptation structure comprises a plurality of struts; atleast a portion of one or more of the struts defines an antenna; andinterrogating the pressure includes establishing a wireless connectionto the pressure sensor via the antenna.
 12. The method of claim 1wherein: the coaptation structure has an anterior surface and aposterior surface; and deploying the coaptation structure includespositioning (a) the posterior surface to engage and displace the firstnative leaflet and (b) the anterior surface to coapt with the secondnative leaflet during systole.
 13. The method of claim 1 whereindeploying the coaptation structure includes positioning the coaptationstructure to remain substantially stationary during the cardiac cycles.14. The method of claim 1, further comprising coupling the pressuresensor to the mitral valve repair device before deploying the coaptationstructure.
 15. A method of monitoring a native mitral valve, the methodcomprising: deploying a coaptation structure of a mitral valve repairdevice such that the coaptation structure displaces a first nativeleaflet of a native mitral valve of a heart and coapts with a secondnative leaflet of the native mitral valve during systole; andinterrogating, via an external device, a sensor of the mitral valverepair device to detect one or more parameters associated with at leastone of cardiac function of the heart and functionality of the mitralvalve repair device.
 16. The method of claim 15 wherein the sensorcomprises a strain gauge and/or an accelerometer coupled to thecoaptation structure, and wherein the one or more parameters comprisemovement of the coaptation structure during the cardiac cycles.
 17. Themethod of claim 15, further comprising deploying an appendage of themitral valve repair device within a left ventricle of the heart suchthat the appendage contacts a wall within the left ventricle of theheart, wherein the sensor comprises a strain gauge and/or anaccelerometer coupled to the appendage, and wherein the one or moreparameters comprise movement of the wall.
 18. The method of claim 15wherein the sensor comprises a microphone, and wherein the one or moreparameters comprise acoustic signals of the heart.
 19. The method ofclaim 15 wherein the sensor comprises a flow sensor coupled to thecoaptation structure, and wherein the one or more parameters comprise aflow pattern through the heart.
 20. A method of monitoring a nativeheart valve, the method comprising: deploying a coaptation structure ofa heart valve repair device such that the coaptation structure displacesa first native leaflet of a native heart valve of a heart and coaptswith a second native leaflet of the native heart valve during systole;and interrogating, via an external device, a pressure sensor of theheart valve repair device to receive pressure data during cardiac cyclesof the heart